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A Trial of SHR - 1906 in Healthy Subjects

Study Purpose

This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study. 2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. Total body weight ≥ 45 kg. 4. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline. 5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.

Exclusion Criteria:

1. History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation. 2. Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial. 3. Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab). 4. Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement. 5. Positive urine drug screening at baseline; 6. Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial. 7. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices. 8. Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening. 9. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response. 10. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guangdong Hengrui Pharmaceutical Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions


Experimental: Cohort 1

A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects

Experimental: Cohort 2

A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects

Experimental: Cohort 3

A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects

Experimental: Cohort 4

A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects

Experimental: Cohort 5

A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects


Drug: - SHR-1906;Placebo

Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Jinan, Shandong, China




Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province

Jinan, Shandong, 250014